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FDA: Alters Diet Supplement Guidelines for Pregnancy

Responding to concerns from consumer advocates and health care providers, the FDA yesterday revised its diet supplement labeling rule, "warning companies not to promote their products as treatments for morning sickness, leg swelling or any other condition affecting pregnant women," the Washington Post reports. The FDA had issued a rule Jan. 5 that narrowed the definition of "disease" and gave diet supplement companies "greater freedom" to make claims that relate to the "structure" or "function" of the human body. But health care experts and others complained that the new rule allowed diet supplements to be marketed to pregnant women when many had never been tested to determine their effect on developing fetuses. Sidney Wolfe, director of the Public Citizen's Health Research Group, said, "Scientifically, everyone knows that the unborn fetus is extremely susceptible, and they (the FDA) should have known this. It's a stupid move to have (issued the rule). At least, they caught it before too much damage was done."

Talk to Your Doc The FDA's statement "urges all pregnant women to consult their health care provider before taking any dietary supplements or medication." The FDA's revision appears to be a "nonbinding advisory," but Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the agency "would evaluate whether [it] should take some action" against companies that ignored the warning. Margaret Dotzel, acting FDA commissioner for policy, added that the agency "intends to hold a public meeting sometime in the near future to discuss 'the safety concerns that have been raised'" (Gugliotta, 2/10). Donna Edenhart, spokesperson for the Consumer Healthcare Products Association, which represents supplement manufacturers, said, "We feel that the FDA is acting responsibly in addressing this question" (Stolberg, New York Times, 2/10).

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